Manager, Global Regulatory Affairs
Posted on Oct 8, 2024 by Biogen
South San Francisco, CA
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
Job Description
Biogen's West Coast Hub located in South San Francisco, CA is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
About this Role:
We are seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). You will be asked to participate on cross-functional project teams on an agenda-driven basis along with providing support for the GRL as needed. You will support development of US label and work collaboratively with the team to ensure implementation of the US label, which includes providing guidance regarding US labeling precedence to the cross functional teams. You will be responsible for interfacing with Regulatory Operations and CROs to support various submissions to Health Authorities, in support of investigational applications, clinical trial applications, and/or marketing authorizations. Additionally, you will support the GRL and cross functional teams on major submissions related to initial Investigational New Drug (IND) and/or New Drug Application (NDA)/Biologics Licensing Application (BLA) submissions, and supplemental applications, as needed.
What You’ll Do:
You must exhibit excellent operational competences, including planning, organizing and other project management skills.
You demonstrate solid oral and written communication skills.
You can independently build networks with cross-functional team members to support collaboration and generate innovative solutions by identifying novel approaches to address work challenges and opportunities.
You have knowledge and understanding of applicable regulations, including experience in interpretation of regulations, guidelines, and policy statements.
Who You Are:
In addition to having exceptional relationship building, you successfully worked in a matrix environment where you collaborated with other teams within the organization. You generate innovative solutions in work situations and build on your networks to obtain cooperation without relying on authority.
This position is preferred to sit as a hybrid role in South San Francisco, CA, however the hiring team is open to US-remote talent.
Biogen's West Coast Hub located in South San Francisco, CA is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
About this Role:
We are seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). You will be asked to participate on cross-functional project teams on an agenda-driven basis along with providing support for the GRL as needed. You will support development of US label and work collaboratively with the team to ensure implementation of the US label, which includes providing guidance regarding US labeling precedence to the cross functional teams. You will be responsible for interfacing with Regulatory Operations and CROs to support various submissions to Health Authorities, in support of investigational applications, clinical trial applications, and/or marketing authorizations. Additionally, you will support the GRL and cross functional teams on major submissions related to initial Investigational New Drug (IND) and/or New Drug Application (NDA)/Biologics Licensing Application (BLA) submissions, and supplemental applications, as needed.
What You’ll Do:
You must exhibit excellent operational competences, including planning, organizing and other project management skills.
You demonstrate solid oral and written communication skills.
You can independently build networks with cross-functional team members to support collaboration and generate innovative solutions by identifying novel approaches to address work challenges and opportunities.
You have knowledge and understanding of applicable regulations, including experience in interpretation of regulations, guidelines, and policy statements.
Who You Are:
In addition to having exceptional relationship building, you successfully worked in a matrix environment where you collaborated with other teams within the organization. You generate innovative solutions in work situations and build on your networks to obtain cooperation without relying on authority.
This position is preferred to sit as a hybrid role in South San Francisco, CA, however the hiring team is open to US-remote talent.
Reference: 203645331
https://jobs.careeraddict.com/post/96021549
Manager, Global Regulatory Affairs
Posted on Oct 8, 2024 by Biogen
South San Francisco, CA
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
Job Description
Biogen's West Coast Hub located in South San Francisco, CA is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
About this Role:
We are seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). You will be asked to participate on cross-functional project teams on an agenda-driven basis along with providing support for the GRL as needed. You will support development of US label and work collaboratively with the team to ensure implementation of the US label, which includes providing guidance regarding US labeling precedence to the cross functional teams. You will be responsible for interfacing with Regulatory Operations and CROs to support various submissions to Health Authorities, in support of investigational applications, clinical trial applications, and/or marketing authorizations. Additionally, you will support the GRL and cross functional teams on major submissions related to initial Investigational New Drug (IND) and/or New Drug Application (NDA)/Biologics Licensing Application (BLA) submissions, and supplemental applications, as needed.
What You’ll Do:
You must exhibit excellent operational competences, including planning, organizing and other project management skills.
You demonstrate solid oral and written communication skills.
You can independently build networks with cross-functional team members to support collaboration and generate innovative solutions by identifying novel approaches to address work challenges and opportunities.
You have knowledge and understanding of applicable regulations, including experience in interpretation of regulations, guidelines, and policy statements.
Who You Are:
In addition to having exceptional relationship building, you successfully worked in a matrix environment where you collaborated with other teams within the organization. You generate innovative solutions in work situations and build on your networks to obtain cooperation without relying on authority.
This position is preferred to sit as a hybrid role in South San Francisco, CA, however the hiring team is open to US-remote talent.
Biogen's West Coast Hub located in South San Francisco, CA is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
About this Role:
We are seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). You will be asked to participate on cross-functional project teams on an agenda-driven basis along with providing support for the GRL as needed. You will support development of US label and work collaboratively with the team to ensure implementation of the US label, which includes providing guidance regarding US labeling precedence to the cross functional teams. You will be responsible for interfacing with Regulatory Operations and CROs to support various submissions to Health Authorities, in support of investigational applications, clinical trial applications, and/or marketing authorizations. Additionally, you will support the GRL and cross functional teams on major submissions related to initial Investigational New Drug (IND) and/or New Drug Application (NDA)/Biologics Licensing Application (BLA) submissions, and supplemental applications, as needed.
What You’ll Do:
You must exhibit excellent operational competences, including planning, organizing and other project management skills.
You demonstrate solid oral and written communication skills.
You can independently build networks with cross-functional team members to support collaboration and generate innovative solutions by identifying novel approaches to address work challenges and opportunities.
You have knowledge and understanding of applicable regulations, including experience in interpretation of regulations, guidelines, and policy statements.
Who You Are:
In addition to having exceptional relationship building, you successfully worked in a matrix environment where you collaborated with other teams within the organization. You generate innovative solutions in work situations and build on your networks to obtain cooperation without relying on authority.
This position is preferred to sit as a hybrid role in South San Francisco, CA, however the hiring team is open to US-remote talent.
Reference: 203645331
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